Rheumatoid Arthritis Drug Approved by US FDA: Pfizer’s Xeljanz Pill (Tofacitinib)
For over two and a half years, we’ve followed Pfizer’s tofacitinib through clinical trials for FDA approval. Today, the U.S. FDA approved the new drug that will be called Xeljanz. Click here to read the full Pfizer press release for Xeljanz.
The first JAK for Rheumatoid Arthritis approved: “Xeljanz”
The U.S. Food and Drug Administration (FDA) announced approval of Pfizer’s new oral medication for Rheumatoid Arthritis (RA) about two weeks earlier than expected. The new brand name for tofacitinib, Xeljanz, was announced by Pfizer in its press release today. Xeljanz is the first new oral treatment to be approved for RA by the FDA in over ten years, and the first approved Janus kinase inhibitor.
Janus kinase or JAK inhibitors are a new class of medicines that inhibit JAK signaling pathways in the immune system. This is considered a novel approach to the treatment of RA. However, like Biologics such as Humira and Actemra, Xeljanz works by specifically interfering with certain modes of inflammatory activity. Other JAK compounds are in the pipeline such as Eli Lilly’s (Incyte) baricitinib.
Xeljanz and Rheumatoid Arthritis treatment
Who can take Xeljanz?
Xeljanz is approved for people with moderate to severely active RA who do not respond to methotrexate or cannot tolerate methotrexate.
How will Xeljanz be used?
Xeljanz will be given as a 5 mg tablet twice per day either alone or with another disease modifying drug such as methotrexate. (Note: there was a 10 mg dose in some of the trials, but it was not approved yet by FDA.)
How much will Xeljanz cost?
According to Pfizer, the wholesale price will be over two thousand dollars per month, slightly less than Biologics such as Enbrel and Humira.
How long will it be until Xeljanz is available?
According to an industry representative, Xeljanz could be available to pharmacies in a few weeks.
How is Xeljanz different from other RA treatments?
Xeljanz inhibits Janus kinase (JAK), a protein that acts as a hub in the cytokine network that creates inflammation. Other treatments for RA (Biologics) interfere with the specific receptors of various immune cells such as TNF (Humira), T-cells (Orencia), B-cells (Rituxan), or IL-6 (Actemra). Xeljanz (tofacitinib) targets a broader phase of the inflammatory process.
How can we learn more about Xeljanz?
At the American College of Rheumatology (ACR) 2012 Annual Scientific Meeting in Washington, D.C., this coming week, Pfizer will present 14 abstracts on their phase three data for Xeljanz. RA Warrior will be reporting from the ACR meeting as in previous years. Pfizer has also created a website for Xeljanz for patients and professionals.
What about side effects and risks?
Click here to read Xeljanz safety information. Log onto their Xeljanz website to learn more.
What about a patient assistance program for Xeljanz?
Yes, it looks like that’s been set up. There is a link for more information on the xeljanz.com site. We’ll provide more information on this as it is available.
Recommended reading
- The End of the Methotrexate Shortage, Thanks to Pfizer?
- Click here to see all JAK articles on RA Warrior
- The 10 Fundamentals of Care for Rheumatoid Patients
I’d love to try a new drug. My liver can’t tolerate Methotrexate and Enbrel offers only partial results. It is not keeping the disease under control, just slowing the damage down somewhat. My Rhuematologist said that switching to another biologic only gives you a 20% chance of significant improvement. He’s added 2 other drugs but my stomach can’t tolerate taking them twice a day. So a new drug at least gives some hope that I will still be able to function in 10 years.
Hi Julie, your doc is right that the odds of one biologic working do go down after another fails. Not sure how this will fit into that since Xeljanz is not a biologic. My hope is that it will help some who have not been helped yet.
Just wanted to comment on subsequent Biologics not being as effective…I am currently taking my 7th Biologic (Actemra) and it is working GREAT right now!!! I have been on it for 2 years now…It was designed for people who have not had an adequate response to other Biologics such as the TNF’s…Hopefully this new medication works differently too so that it may be effective even if the patient has failed several Biologics…
Jewell
Jewell. Actemra supposedly reduces cytokine interleukin 6
Was your il 6 high on blood work?
I tried 3 anti TNF’s that stopped working and Remicade was supposed to not only reduce TNF AND Il6 but mine doubled after 3 infusions. I am going to try this new oral first since it may get to the hub if the problem. Was wondering WHY they put you in Actemra and how long it took to act
Joanne
Julie, I’m certainly not arguing against your doctor’s experience and knowledge, but one biologic can produce a significant improvement over the performance of another, at least in my and my rheumatologist’s experience. I took Enbrel for about a year and did find that it produced some improvement, for which I was grateful. My rheumatologist was not satisfied with my improvement and wanted me to try another. I was at first unwilling because I could at least function on some level with Enbrel, even if I was far from a 70 percent return to my former self. He finally convinced me that I should try. The results have been remarkable. I don’t know how long they’ll last. I seemed to do better on Enbrel in the beginning and the effectiveness waned, but it was never what it has been since my first Humira injection. I still have RA. I still have to find ways to keep the covers off my feet some nights because it hurts too much to sleep otherwise. But that buzzing, fiery burning through my bones and body is gone, and with it, the extreme exhaustion. It’s amazing for now, and I intend to enjoy it while it lasts. It’s great that we all have another alternative and hope in this new drug, too.
A new drug that attacks the disease from a different angle might work for some, I think it depends on what is making that person’s disease more active. If this drug attacks a different component to the inflammation maybe it will work for some who aren’t finding good results with other drugs. It’s worth a try. Of course then there’s always the question, “will my insurance cover the new drug”. Fortunately I have coverage through my work and also my husbands. Mine doesn’t cover Enbrel but my husband’s does thankfully. It gets expensive paying for double coverage but still far cheaper than the drugs.
I was hoping to read of a significant advantage in either the side effect profile or the cost, but it looks to be similar to the biologics on both counts. Even so, any new option is good to have, and I hope it will be of help to those the current drugs don’t help.
I carelessly called xeljanz a biologic earlier. I was just trying to say that it’s function is similar to biologics but it’s a pill. We might find ourselves replacing our biologics with it. Since it’s names are tofacitinib and xeljanz I propose it be called “tofu jello”.
I just saw my rheumy yesterday, talking about what the future holds. He said the real hope is gene therapy far far in the future, but for now we’ll continue trial and error hitting parts of the immune system until our bodies find away around it and then we try something else.
I am *so grateful* to have another drug available!!!
I think there were incidences of elevated cholesterol and liver enzymes with this new drug, so that’s something to discuss with one’s doctor.
Interesting that it would be priced just a bit lower (about $2,000 for a month supply) than biologics. I realize there is the cost of research and development to recoup, but I would think the manufacture of a pill would be less costly than producing biologics in syringes that have to be refrigerated.
I wonder how insurers will classify this drug. If as a Tier IV drug, coinsurance could be several hundred dollars a month.
If it causes elevated cholesterol it might be out of the question for me. Bad genetics mean I already have rather high cholesterol and take 2 meds to keep it somewhat under control. Bummer…
Linda, thanks for your experience with Humira, I will consider it but don’t really want to go off the Enbrel at the moment. I’m still moderately functional although having quite a bit of pain lately. Snowboard season is just around the corner though so any med change will have to wait until late spring or early summer. I don’t know how many more seasons I’ll be able to snowboard so I’m not going to miss one now because of having to go off my med for a bit before I start the next.
Julie, I certainly wasn’t trying to convince you to switch before either your or your doctor believes that’s a wise thing to do. I just wanted you to know that if it becomes necessary, some people have had much different results with two biologics. Maybe I and the other responder with a similar experience when switching are in the very low minority of people.
Tofu jello has me laughing hysterically…thank you for the giggle.
JAKs….make me hopeful. I guess I would be willing to try almost anything at this point, because the biologics failed miserably, the infusions are failing currently, and I would like the use of my elbows back again! (C’mon, they’re not even weight bearing. Why would they hurt so much? Oh yes, because RA is MEAN.)
I’m currently shopping for a new Rheumy (last one’s office staff drove me away) but once I get settled in, I think we will need to have a JAK talk.
Please pass the tofu jello. 🙂
Jennifer
As a question (yes I know I posted three responses, sorry about that, my brain is working in shifts today.)
As a question, I am wondering where it says “monitor liver” I have monitored my liver for all my drugs, that’s nothing new. However, my Actemra (current infusion drug) raises cholesterol, which is BAD (understatement), since heart disease is an early death for RA patients.
I’m not seeing anything on JAKs regarding cholesterol. I wonder if it is still too early, though I think that would be obvious and show up early.
Just a thought…
not positive Jennifer and we’ll probably know more about that after next week, but I think cholesterol is something to watch. I found a few abstracts when I googled “JAK tofacitinib cholesterol” – here’s one: http://www.ncbi.nlm.nih.gov/pubmed/19565475
My doc never mentioned that my severe fatigue could be from my RA. Hell Im not getting any help from him in the first place. Ive been on over 9 meds as well as infusions and shots. Im so tired through out the day. At night I can go to sleep but I wake up and have had only about four hours of sleep. I dont know what to do.
I put this reply in the wrong area lol.
I want to my Rummy on Nov 21, to get a refill on Cimzia. Well he told me about Xeljanz and it sound great. I did some research and now I feel the risk is to high. I have been on Enbrel, Humira and now Cimzia for 1 1/2 years. I do not know why but Cimzia works as good or better then the other two. How can I tell, well I am only doing one injection a month instead of 2. I feel better and so far no side effects. Just had blood work done and all clear. So I not going to mess with what is working at this time. The only reason my Rummy wanted to offer me this is because Cimzia shot are not so easy, but I can live with a little PITA.
Xeljanx not available to all. I have been calling daily speciality pharmacy since I am getting worse daily. Humira, Simponi, Remicade, Enbrel, MTX, PRED, nothing working. I walk like a hundred, depression is hard to fight off and now I thought this expensive drug would help. I have the very best of medicare D supplement plan and pay a lot for it, but I read – and also called Blue Cross and this is a statement that I simply cannot understand. ‘BLUE CROSS WILL ADD XELJANX TO THEIR PHARMACY MANAGEMENT PROGRAM, WHICH MEANS DRUG WILL REQUIRE PRIOR REVIEW AND QUANTITY MANAGEMENT. THESE REQUIREMENTS, HOWEVER, WILL NOT APPLY TO FEDERAL OR STATE EMPLOYEES OR MEDICARE PART D MEMBERS OR ANY GROUP THAT CARVES OUT THEIR BENEFITS TO ANOTHER PHARMACY.
At first, I thought, that’s good. No prior review etc. But when I called they said Xeljanx will NOT be on their drug list and is called a non-formulary drug. They gave no explanation. Walgreens does not even have it listed yet. The statement above is quite confusing. It cannot be the price for Simponi, etc. are expensive biologics that I received so why would this be different. Few can afford the $2500 monthly price tag. I am going to call Phizer and ask what is going on
I alm also calling AARP since I have their United Health Care drug supplement and ask them as well. It seems if the drug is going to do well on the market, it should be made available to everyone. Since I not on medicaid and am not in the povery level, it seems I do not qualify for anything in the middle class position.
If anyone knows anymore than I do about this, please advise.
Every day, as we all know, is a struggle. I never though it would get my legs but it did, then my knees, then my shoulders. How many replacements can one have and still have pain. My ELBOW, for heaven’s sakes, was for a few months, and nothing, not even PRED would bring it down. I am now going to try my last resort, Actemra, since when I had REMICADE infusion, my interleukin 6 (IL6) went up DOUBLE!
That is when I did the “lucky lucky me dance”.
Actemra is my last bastion, but I was hoping Xeljanx would get at the “hub” of the matter, as it suggests.
Thanks. Keep up the good fight. There is something out there for us. I will never give up. Never!
Just dropped off my Rx for Xeljanz at the pharmacy, waiting to hear about any insurance hurdles (Pfizer does have a nice copay card, at least for the next year).
I have been waiting for this since I had to stop taking Humira (which was working!) over a year ago due to a rash… here’s hoping it’s my silver bullet!
What is the co pay. I got authorization from doctor to give to Pfizer. Good for one year. Some pharmacies have it. Some do not – they have to see if you are eligible before they order it since it is so expensive for them to hold in stock. Am anxious to try if not I try Actemra but am running out of BIOLOGICS. All stopped working. Will let all know
I just got a one month supply of Xeljanz from my doc today, will start on Sunday. I’m hopeful my pharmacy stuff will be straightened out again. I am the 5th patient the rheumy has starting it. Best of luck Tracey! I’ve got my swollen fingers crossed for myself too.
Glad to hear it. 🙂
I started Xeljanz the last week of November. It has been a month now, it seems like I can already tell a difference. What I am noticing is my symptoms are much, much milder and come and go more quickly. I am still on Enbrel, had to stop Azothioprine so my Crohn’s is going nuts. Or it could be the diarrhea side effect of the Xeljanz? I would like to know if there’s a forum somewhere with other patients using this med to chat about it.
As for availability, I’ve not had a terrible problem getting it. My insurance didn’t require any special approval, no different than a script of antibiotics. Did have a bit of a nervous pharmacy about ordering and being stuck with it (I was traveling at the time of the first filling so while it was within my chain, it was a new location) it did take a day to get it in stock and they didn’t label it/sticker it until I was there in person to get it.
I see there’s financial support from Pfizer for the co-pay. I have a reminder note to call in tomorrow morning and ask about getting on that. I have that for Enbrel, too. I wonder since that is also Pfizer (by way of Amgen I guess?) if I can qualify for assistance for both meds?
I just know I miss my Humira but the side effects were too much so they won’t let me have that.
Ali, Does your doctor know you took the Xeljanz at the same time you are still on Enbrel? I didn’t think it was approved to use with a biologic. Yes, the side effect could be from the medicine. I’ll put up a post in a couple days that we can use as a forum for Xeljanz – I have something planned so check back. Are you subscribed to get the blog posts in your email yet?
The co-pay seems to be pretty straight forward. I’ve spoken with them.
Our systems are so different – I had no side effects from Humira but it quit helping me very quickly if it ever helped much.
I am shocked your doctor or even pharmacist is letting you take Enbrel and Xeljanz together!! Read info on it. I have bed taking Xeljanz for 1 month and it is working well but my cholesterol total on tests were a tad high and I do not have high cholesterol
Yes, he’s aware I’m on both. I was on double doses of both Humira and Enbrel for a time. I get a lupus reaction from Humira, which is too bad because it worked wonders for my Crohn’s. The Azothiriopine was keeping me steady in its place. I just this week started the old antibiotic cycle to try to get on top of the Crohn’s.
They have me on Enbrel still because it is keeping my spine from getting worse (from AS).
They have not been able to come close to finding meds that can control the disease processes. It was to the point I was housebound with home health nurses, PT & OT coming to my home. It really seems the xeljanz is working. This is so surprising! It is not for the AS though, I can tell because when I’m getting lax on my Enbrel it reaches the point I can’t find a position I’m not at a 6 or 7.
Called this morning, Kelly you’re right, the financial assistance was very straightforward… I just pay a flat $4. That’s nice! I guess Enbrel is not Pfizer at all? Need to call to ensure I have coverage for the new year for Enbrel, particularly since my husband just got laid off, sigh.
My doctor just gave me the new drug xeljanz. I am wondering if anyone has any side effects? I am very nervous about tnis drug. Its so new…… i suffer so bad and have so many flairups.
Hi all…I am on methotrexate which has somewhat helps but not majorly better…my Rheumy write in to overwrite the 2k a month payment for xelganz…he kept me on metho..I tried and exhausted just about every med and could not take them…I only been on this new drug a week n a half with only 5 ng to start me slow…well to no aveil side effects kickung in and I want to croak…so sick and started reading side effects on it…I had to stop it and it was free for me…my question to anyone is how long does it fully take to get out of my system and my body get rid of side effects??? To e1 trying it gk to u all..wishing everyone pain free days!! Linda in Pa
What kind of side effects?
I know the ad is just a marketing ploy, but I still think it’s a better message than most of the ads!
I esp. like the inclusion of feet! That really hit home w/me as lately my feet havembeen very painful and swollen. I can hardly walk sometimes. I’ve been trying physicalmtherapy to strengthen my core and help me w/balance. But I’ve had to cancel numerous times because of flares. I have been on prednisone and methotrexate for the 16 years since I was diagnosed w/RA. I also did the study for orencia for 5 years and now get infusions monthly. There is a caveat there: I cannot have any infections nor can I have taken antibiotics 2 weeks prior! Well, my skin is very thin now and it bruises and tears, often turning into a minor infection. That, combined w/an out real of Mrsa a couple times a year, bronchitis and pneumonia at least once a year, means I’m on antibiotics a lot and can’t get the orencia! The worst part for me now is my rheumy took me off relafen, the wonderful anti-inflammatory I had taken since I was first diagnosed. My kidney numbers were bad so he sent me to a nephrologist, who says no more relafen, period! So I’m going to ask my extremely cautious rheumy if he’ll let me try xjelzanze (sp!). Wish me luck!
Xeljanz has been a godsend. I am only sorry that my joints are so far gone. No inflammation. Nothing. It worked right away. My blood tests are all normal. Stopped MTX. Nothing else was working. My interleukin 6 was high. Everything normal. Where was this years ago?
I have been on Xeljanz for 3 yrs and it has been great until recently, doctor want to “add” Orencia to it. No issues at all with Xeljanz.
HI Guys
Just like to seek any ones thoughts or experience im a little lost and jaded.. with the use of Xeljanz pill and Actemra Infusions..
I was on Actemra for about a year now with a weekly dose of MTX and then my Rheumy then said why not give Xeljanz a go as its getting good results. I am now 3 months on these pills and well to be honest not finding it as good as the monthly Actemra infusion.
I was wondering if any one has had this experience or situation..
The actmera worked fine but sort of tapered of towards the end of each month the last week of the month was ok but annoying.. then Boom another infusion and all was good hehe.
The Xeljanz worked straight away but I noticed at least a 30% increase in pain and over all tiredness.. mornings really suck.. its steady but do not find it as good.
Thanks every one for all the posts they really make life with RA more positive..
Rgds
Rory